NCT07132567

Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.

Detailed description

This post-marketing surveillance (PMS) is designed as an all-case investigation in accordance with the Korean Ministry of Food and Drug Safety (MFDS) re-examination requirements. It targets adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy and are treated with mogamulizumab (POTELIGEO® Injection 20 mg) under the approved indication in Korea. Primary Objective: To assess the safety of mogamulizumab for patients treated under the approved indication in Korea. Secondary Objective: To assess the effectiveness of mogamulizumab for patients treated under the approved indication in Korea. Exploratory Objective: To perform additional subgroup and exploratory analyses of effectiveness, including evaluation in special populations such as elderly patients, patients with renal or hepatic impairment, and those with a history of hematopoietic stem cell transplantation, treated under the approved indication in Korea

Conditions

• Mycosis Fungoides
• Sezary Syndrome

Interventions

Type	Name	Description
DRUG	Poteligeo 20mg	Poteligeo 20mg

Timeline

• Start date: 2025-05-02
• Primary completion: 2028-09-01
• Completion: 2028-11-01
• First posted: 2025-08-20
• Last updated: 2025-09-22

Locations

6 sites across 1 country: South Korea